Phase II Trial of Weekly Docetaxel (Taxotere) Vs. Weekly Docetaxel in Combination With ZD1839 (Iressa®) As Consolidation Therapy For Metastatic Urothelial Cancer Following Maximal Response To Multi-Agent Chemotherapy
Docetaxel is a drug designed to help stop cancer cells from growing and dividing. ZD1839 is
also a drug designed to block cancer cells from growing and dividing.
Before treatment starts, you will have a complete physical exam. Blood (2-3 tablespoons) and
urine tests will be taken as part of the usual evaluation of liver, bone marrow, blood
clotting ability, and kidney function. A chest x-ray and ECG (test to measure the
electrical activity of the heart) will be done. You will have imaging studies such as a CT
scan of the chest abdomen and pelvis and a bone scan to show the location of current tumors.
If needed, an MRI scan of the brain will be done. This evaluation is considered standard.
Women who are able to have children must have a negative blood pregnancy test. Patients who
have a history of invasive tumors in their bladder, and who have not had a prior cystoscopy,
must have a screening cystoscopy with an EUA (examination under anesthesia), to check the
extent of disease in their bladder. An EUA of the bladder is a standard procedure for
diagnosing and checking the status of bladder cancer.
You will be randomly assigned (as in the toss of a coin) to one of two treatment groups.
Participants in one group will receive docetaxel alone. Participants in the other group will
receive docetaxel plus ZD1839. There is an equal chance of being assigned to either group.
Both you and the study doctor will know to which group you were assigned.
Docetaxel will be given through a catheter (a plastic tube) placed in a large vein in the
chest or arm. The medication will be given over about thirty minutes one day each week for
4 weeks. This will be followed by a 2 week break. The 4 weeks of treatment and 2 weeks
without treatment will be considered one course (6 weeks).
Dexamethasone will be given to decrease the risk of having an allergic reaction to the
docetaxel. In the first cycle, you will receive 3 doses of dexamethasone by mouth every 12
hours starting the night before the docetaxel infusion. If you have no reaction, the
dexamethasone will be decreased in Course 2 to one dose twice on the day of therapy. If
there is no reaction in Course 2, the dexamethasone will be decreased further to 1 dose 1
hour before docetaxel treatment.
ZD1839 is a medication taken by mouth every day without break. Participants in the docetaxel
plus ZD1839 group will take one ZD1839 tablet once a day at about the same time. You can
take ZD1839 with or without food. If you forget to take a dose, take the last missed dose as
soon as you remember, as long as it is at least 12 hours before the next dose is due. If it
is less than 12 hours until the next dose, do not take the dose you have missed.
During treatment, you will have a weekly blood test (2-3 tablespoons) to measure bone marrow
function. A physical exam and blood tests (2-3 tablespoons) will be repeated before each
cycle of treatment. Imaging studies will be repeated at 9 months but may be performed
sooner if you have symptoms that show your tumor may be getting worse. These scans are
considered part of standard routine follow-up.
You will be on study as long as the tumor is not growing at a certain rate and there are no
severe side effects. Therapy will be stopped and you may be taken off study early if one or
both of these things occur. After 6 months, patients can choose to continue therapy if they
wish. At the end of 4 cycles, you will have the option to continue your assigned therapy as
long as it is tolerated and there is no evidence that the disease is getting worse. There is
no maximum amount of time that you can receive treatment on this study.
After the study is complete, follow-up will be arranged at the discretion of your treating
This is an investigational study. The FDA has authorized ZD1839 for research use only. A
total of 90 patients may take part in this study. All will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients Free From Progression 9 months from Start of Consolidation Therapy
Arlene Siefker-Radtke, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|